US20050222517A1 - Rectal probe with disposable balloon assembly - Google Patents
Rectal probe with disposable balloon assembly Download PDFInfo
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- US20050222517A1 US20050222517A1 US11/091,107 US9110705A US2005222517A1 US 20050222517 A1 US20050222517 A1 US 20050222517A1 US 9110705 A US9110705 A US 9110705A US 2005222517 A1 US2005222517 A1 US 2005222517A1
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- balloon
- interior space
- sleeve
- temperature sensor
- handle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
- A61B5/4375—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the male reproductive system
- A61B5/4381—Prostate evaluation or disorder diagnosis
Definitions
- the present invention relates to a temperature sensing probe for sensing rectal temperature of a patient.
- the present invention relates to a temperature sensing probe comprising a reusable handle and sensor array with a disposable balloon/sleeve assembly.
- the prostate gland is a complex, chestnut-shaped organ which encircles the urethra immediately below the bladder and lies immediately adjacent the rectum.
- This relatively small organ which is the most frequently diseased of all internal organs, is the site of a common affliction among older men, benign prostatic hyperplasia (BPH), as well as a more serious affliction, cancer.
- BPH is a non-malignant, bilateral nodular tumorous expansion of prostate tissue occurring mainly in the transition zone of the prostate. Left untreated, BPH causes obstruction of the urethra which usually results in increased urinary frequency, urgency, incontinence, nocturia and slow or interrupted urinary stream. BPH may also result in more severe complications, such as urinary tract infection, acute urinary retention, hydronephrosis and uraemia.
- a fairly recent treatment method for BPH involves microwave thermal therapy, in which microwave energy is employed to elevate the temperature of tissue surrounding the prostatic urethra above about 45° C., thereby thermally damaging the tumorous BPH tissue.
- Delivery of microwave energy to tumorous prostatic tissue is generally accomplished by a microwave antenna-containing applicator, which is positioned within a body cavity adjacent the prostate gland.
- the microwave antenna when energized, heats adjacent tissue due to molecular excitation and generates a radiation pattern which encompasses and necroses the tumorous prostatic tissue.
- the necrosed intraprostatic tissue is subsequently reabsorbed by the body, thereby relieving an individual from the symptoms of BPH.
- transurethral microwave thermotherapy One type of thermal therapy treatment of BPH is transurethral microwave thermotherapy. This method of treatment positions a Foley-type catheter containing a microwave antenna within the urethra adjacent to the prostate gland. The microwave antenna is energized to heat a selected volume of tumorous prostatic tissue surrounding the urethra to about 45° C. for a time sufficient to necrose the selected volume of tissue.
- the temperature of rectal tissue adjacent the prostate is measured and monitored with a rectal temperature sensing probe.
- the probe supports one or more temperature sensing elements against a wall of the rectum adjacent to the prostate to provide the physician with essential information for controlling the location and degree of heat induced in the prostate.
- the present invention is a temperature sensing probe assembly comprising a reusable temperature sensor/handle assembly and a balloon/sleeve assembly.
- the temperature sensor/handle assembly is comprised of a handle having a length, a width, a first end and a second end, and a temperature sensor strip carried by the handle and extending from the first end of the handle.
- the temperature sensor strip comprises a temperature sensor spaced from the first end.
- the temperature sensor is configured for connection to a thermometry device.
- the balloon/sleeve assembly comprises opposing first and second polymeric layers configured to define a balloon portion and a sleeve portion.
- the balloon portion further comprising a first interior space in communication with an interior space of the sleeve portion, and a second interior space isolated from the first interior space and the interior space of the sleeve portion.
- a first tube portion of an inflation tube is sealingly connected within the second interior space of the balloon portion and is configured with an inflation port.
- a second tube portion of the inflation tube extends through the sleeve portion and is configured for connection to a fluid source.
- the handle is reversibly positionable within the sleeve portion and the temperature sensor strip is reversibly positionable within the first interior space of the balloon portion.
- FIG. 1 is a top view of the rectal temperature sensing probe of the present invention.
- FIG. 2 is a bottom view of the rectal temperature sensing probe of FIG. 1 .
- FIG. 3 is a bottom exploded view of the rectal temperature sensing probe of FIG. 1 .
- FIG. 4 is an enlarged perspective view of the reusable probe handle and temperature sensor array of the rectal temperature sensing probe of the present invention.
- FIG. 5 is an exploded perspective view of the single use balloon/sleeve assembly of the rectal temperature sensing probe of the present invention.
- FIG. 6 is a cross-sectional view of the balloon/sleeve assembly of the present invention taken along line 6 - 6 of FIG. 1 .
- FIG. 7 is a top view of the rectal temperature sensing probe of the present invention with the temperature sensing array partially inserted in a guide tube of the balloon/sleeve assembly.
- FIG. 1 is a top view of the rectal temperature sensing probe 10 of the present invention.
- probe 10 is generally comprised of a probe handle 12 and a balloon/sleeve assembly 14 .
- the probe handle 12 includes a handle body 16 and a temperature sensor array 18 which carries a plurality of longitudinally spaced temperature sensors 20 .
- handle 16 is preferably formed of silicone in a molding process that captures a sensor cable 22 , which is electrically connected to sensor array 18 .
- Handle body 16 has a length of about 6.0 inches to about 6.5 inches and a nominal diameter of about 0.5 inches.
- Temperature sensor array 18 is comprised of the plurality of temperature sensors 20 bonded to a flexible circuit which is housed within a protective strip.
- a suitable temperature sensor array is fully described in U.S. Pat. No. 5,792,070, which is incorporated herein by reference.
- temperature sensor array 18 extends from a proximal end 24 of handle body 16 , with temperature sensor 20 A positioned approximately 1.75 inches to about 2.15 inches from proximal end 24 .
- Temperature sensor array 18 has a length extending from proximal end 24 of handle body 16 of about 4.4 inches to about 4.6 inches.
- Temperature sensors 20 are oriented and spaced to sense a temperature of a wall of the rectum facing the prostate when probe 10 is properly positioned within the rectum of a patient undergoing a heat treatment of the prostate.
- Sensor cable 22 is configured for connection to a rectal thermometry unit to transmit a signal representative of the sensed wall temperature, as is fully described in the aforementioned U.S. Pat. No. 5,792,070.
- the balloon/sleeve assembly 14 includes a balloon portion 26 , which holds and carries temperature sensor array 18 , and a sleeve portion 28 , which enshrouds a portion of the handle body 16 .
- the balloon/sleeve assembly 14 is designed to be a disposable unit that can be separated from the probe handle 12 after use of probe 10 .
- the balloon portion 26 and sleeve portion 28 are formed from layers of a flexible, biocompatible polymer, such as polyurethane, in a manner to be more fully described. As shown in FIG. 1 , the balloon portion 26 and sleeve portion 28 may be transparent to enable verification of a proper positioning of the temperature sensor array 18 within the balloon portion 26 .
- the balloon portion 26 is formed with a central channel 30 , which positions temperature sensor array 18 in a proper orientation relative to an outer surface 32 of the balloon portion 26 .
- proximal end 24 of the probe handle 12 lies generally adjacent to a waist 34 of the balloon portion 26 , which is a point of transition from the balloon portion 26 to the sleeve portion 28 .
- Balloon portion 26 is dimensioned to fit within the rectum of a patient and engage the rectal wall when the balloon portion 26 is inflated, with the proximal end 24 of the probe handle 12 remaining external to the rectum.
- An inflation tube 36 which is in communication with a fluid source, extends along the probe handle 12 and into the balloon portion 26 to inflate the balloon portion 26 .
- the sleeve portion 28 is sized to permit easy assembly and disassembly of the probe handle 12 from the balloon/sleeve assembly 14 and to cover the handle body 16 when probe 10 is in use.
- FIG. 2 is a bottom view of the probe 10 of FIG. 1 .
- inflation tube 36 extends along the probe handle body 16 within a channel 38 formed relative to a bottom surface 40 of handle body 16 .
- Inflation tube 36 extends to a tip 42 of balloon portion 26 and is configured with a bulbous end 44 in contact with the tip 42 .
- the bulbous end 44 is fixed relative to the inflation tube 36 to provide a blunt surface in contact with an inner surface of balloon portion 26 for the safety of the patient in the event tip 42 contacts patient tissues.
- inflation tube 36 is provided with a plurality of openings 46 within balloon portion 26 for the introduction of an inflation medium.
- the plurality of openings 46 are oriented on opposite sides of inflation tube 36 to provide flexibility in a preferred plane to allow for anterior rectal wall contact of temperature sensors 20 while maintaining column strength/flexural rigidity of inflation tube 36 sufficient for insertion of balloon portion 26 into the rectum.
- the size of openings 46 at or near to waist 36 may increased or elongated.
- Channel 38 of handle body 16 is dimensioned to secure inflation tube 36 relative to handle body 16 when inflation tube 36 is positioned therein. Accordingly, the elongated opening 48 of channel 38 has a width that is less than an outer diameter of inflation tube 36 when handle body 16 is unstressed. Owing to the flexible characteristics of the silicone material forming handle body 16 , the opening 48 , however, can yield sufficiently to permit the inflation tube 36 to be press fit into and removed from channel 38 with an application of sufficient force. In the absence of such force, the edges of opening 48 slightly overlap opposite sides of inflation tube 36 to retain inflation tube 36 within channel 38 .
- a longitudinal movement of inflation tube 36 relative to handle body 16 is prevented by means of a lock assembly formed between a key 50 secured to inflation tube 36 and a corresponding key slot formed in handle body 16 transverse to channel 38 .
- the key slot in handle body 16 is positioned to align with the key 50 when temperature sensing array 18 is fully inserted into central channel 30 .
- the lock assembly further ensures that a precise location of the temperature sensor array 18 within channel 30 (shown in FIG. 1 ) is maintained when probe 10 is in use.
- FIG. 3 is an exploded bottom view of probe 10 with the probe handle 12 separated from the balloon/sleeve assembly 14 .
- probe handle 12 is removable and separable from the balloon/sleeve assembly 14 to permit probe handle 12 , i.e., and the temperature sensing array 18 , to be reused with a new sterile balloon/sleeve assembly.
- the balloon/sleeve assembly 14 includes the inflation tube 36 , which is connected between layers of the polymer material forming a balloon at the waist 34 of the balloon portion 26 , as will be described in greater detail. As shown in FIG.
- the key 50 consists of a polymeric member having a flat edge portion 52 , a curved edge portion 54 and a hole 56 passing through the member to permit key 50 to be slid into a position on inflation tube 36 corresponding to key slot 58 in handle body 16 . Once key 50 is properly positioned, it is secured to inflation tube 36 by a suitable adhesive.
- FIG. 4 is an enlarged perspective view of the probe handle 12 , which shows that the handle body 16 is configured with a curved upper surface 60 and a flat lower surface 62 .
- This configuration of handle body 16 facilitates a proper orientation of the probe 10 relative to a patient and monitoring of the proper orientation during use.
- the flat lower surface 62 of handle body 16 contacts a treatment surface occupied by a patient in the supine position and is maintained in contact with the treatment surface by the weight of the patient on the handle body 16 .
- the configuration of handle body 16 thus inhibits any twisting of probe 10 by minor changes of position of the patient on the treatment surface.
- temperature sensor array 18 extends from the proximal end 24 of handle body 16 at an upper extent of handle body 16 , and sensor cable 22 extends rearward of handle body 16 at a comparable upper extent. Temperature sensor array 18 is oriented in a plane that is generally parallel with the flat lower surface 62 of handle body 16 , with sensors 20 oriented on the upper surface of the flexible circuit.
- Channel 38 is generally centrally located relative to the flat lower surface 62 .
- Channel 38 is defined by a curved inner wall 64 which has an inner diameter that approximates the outer diameter of the inflation tube 36 for retaining the inflation tube 36 in channel 38 .
- the width of opening 48 of channel 38 is smaller than the inner diameter of inner wall 64 , which aids in the retention of inflation tube 36 within channel 38 .
- the key slot 54 is dimensioned and configured complimentary to key 50 to form a friction fit with key 50 when it is position within key slot 54 .
- FIG. 5 is an exploded view of the balloon/sleeve assembly 14 .
- the balloon/sleeve assembly 14 is comprised of a plurality of overlying and interconnected layers 70 , 72 , 74 and 76 which are connected together along a common peripheral edge such as by heat welding.
- Layers 70 and 76 are each a unitary layer of polymer that defines the top and bottom layers, respectively, of balloon portion 26 and the sleeve portion 28 of the balloon/sleeve assembly 14 .
- Edge portion 77 of layers 70 and 76 remain unconnected for inserting and removing probe handle 12 from the balloon/sleeve assembly 14 .
- Layers 72 and 74 are also each a unitary layer of polymer that is a postage stamp of balloon portion 26 , extending from a first end 42 A to an opposite end 78 corresponding to waist 34 of balloon/sleeve assembly 14 .
- Guide tube 80 Positioned between layers 70 and 72 adjacent to end 78 of layer 72 is a guide tube 80 , which facilitates insertion of the temperature sensor array 18 into the balloon portion 26 .
- Guide tube 80 is formed of a flexible polymer, such a Fluorinated Ethylene Plastic or Fluorinated Ethylene Propylene and is skived along a portion of the tube wall facing layer 70 to minimize the amount of material of balloon portion 26 that gets positioned within a patient, i.e., for patient comfort.
- Opposing edge portions 82 of guide tube 80 are secured to the peripheral edge regions of layers 70 and 72 to hold guide tube 80 in place.
- End 78 of layer 72 is left unconnected relative to layer 70 , such that guide tube 80 separates layers 70 and 72 slightly for easy insertion of the temperature sensor array 18 .
- Layers 70 and 72 are further interconnected by heat welding along seal lines 84 which define channel 30 for the temperature sensor array 18 .
- Inflation tube 36 Positioned between layers 74 and 76 is the inflation tube 36 .
- Inflation tube 36 is oriented with the flat edge portion 52 of key 50 facing layer 76 and the axis of openings 46 perpendicular to the flat edge portion 52 of key 50 .
- Inflation tube 36 is sealingly connected between layers 74 and 76 at the waist 34 and along end 78 .
- Layers 74 and 76 thereby define an inflatable balloon, which when inflated results in layer 74 bearing directly against layer 72 and indirectly against layer 70 to urge the temperature sensor array 18 in close proximity to the wall of the rectum to be monitored.
- Layer 76 in turn bears against an opposite rectal wall portion to secure the balloon portion 26 in place in the rectum.
- layers 70 , 72 , 74 and 76 have a wall thickness of about 0.2 mil (i.e., about 0.002 inches), which provides for good heat transfer across layer 70 to sensors 20 of the temperature sensor array 18 .
- balloon/sleeve assembly 14 may comprise only three layers consisting of layers 70 , 72 and 76 that are connected in the manner described above.
- layers 70 and 72 are secured together about the perimeter and guide tube 80 is secured therebetween as previously described.
- Layers 70 and 72 are then heat sealed along seal lines 84 to form channel 30 .
- inflation tube is positioned between layers 76 and 72 and secured by sealing layer 76 to layer 72 about the perimeter and by sealing the side of layer 72 facing layer 76 to layer 76 along end 78 .
- layer 72 may be sized and shaped to define channel 30 and sealed about its perimeter to layer 70 , with guide tube 80 positioned as previously described between layers 70 and 72 .
- Inflation tube is positioned between layers 70 and 76 and secured by sealing layer 70 to layer 76 about the perimeter and by sealing the side of layer 70 facing layer 76 to layer 76 along end 78 .
- FIG. 6 is a cross-sectional view of the waist 34 of balloon portion 26 , which shows the peripheral heat welds 90 that interconnect peripheral edge portions of layers 70 , 72 , 74 and 76 .
- FIG. 6 also shows adhesive layers 92 , which secure the opposing edge portions 82 of guide tube 80 to layers 70 and 72 .
- adhesive layer 94 is shown interconnecting end 78 of layer 74 to layer 76 and inflation tube 36 to create a fluid-tight seal at end 78 and thereby form a balloon between layers 74 and 76 that is inflatable and deflatable via the inflation tube 36 .
- FIG. 7 is a top view of probe handle 12 being introduced into balloon/sleeve assembly 14 for assembly of rectal temperature sensing probe 10 .
- probe handle 12 is inserted through sleeve portion 28 and temperature sensor array 18 is positioned within guide tube 80 .
- Sleeve portion 28 maybe folded back over balloon portion 26 to facilitate locating guide tube 80 .
- guide tube 80 is formed from a distinct color that is readily detectable through the transparent material forming balloon/sleeve assembly 14 , which makes the opening for temperature sensor array 18 into channel 30 easy to identify.
- Probe handle 12 is advanced until temperature sensor array 18 is completely within channel 30 , which occurs when key 50 on inflation tube 36 is aligned with the key slot 54 in the handle body 16 .
- Inflation tube 36 is then press fit through opening 48 and into channel 38 along the length of handle body 16 and key 50 is press fit into key slot 54 .
- temperature sensing probe 10 is then ready for insertion and use in a patient.
- Inflation tube 36 is flexible but with sufficient longitudinal stiffness to enable advancement of tip 42 of balloon portion 26 into the desired position within the rectum of a patient.
- Balloon portion 26 is sized to engage the rectal wall when an inflation medium is introduced via the inflation tube 36 between layers 74 and 76 of the balloon portion 26 . With the inflation medium evacuated from the balloon formed by layers 74 and 76 , balloon portion 26 reduces to a more compact dimension for easy removal of the balloon portion 26 from the patient.
- the sleeve portion 28 is everted over balloon portion 26 to isolate the contaminated surface of balloon portion 26 .
- Inflation tube 36 and key 50 are then easily withdrawn from the channel 38 and key slot 58 in the handle body 16 . With the inflation tube 36 separated from the handle body 16 , probe handle 12 easily slides out of the balloon/sleeve assembly for subsequent re-use with a new balloon/sleeve assembly.
Abstract
Description
- This application claims the benefit of Provisional Application No. 60/558,746 filed Apr. 1, 2004 for RECTAL PROBE WITH DISPOSABLE BALLOON ASSEMBLY”.
- The present invention relates to a temperature sensing probe for sensing rectal temperature of a patient. In particular, the present invention relates to a temperature sensing probe comprising a reusable handle and sensor array with a disposable balloon/sleeve assembly.
- The prostate gland is a complex, chestnut-shaped organ which encircles the urethra immediately below the bladder and lies immediately adjacent the rectum. This relatively small organ, which is the most frequently diseased of all internal organs, is the site of a common affliction among older men, benign prostatic hyperplasia (BPH), as well as a more serious affliction, cancer. BPH is a non-malignant, bilateral nodular tumorous expansion of prostate tissue occurring mainly in the transition zone of the prostate. Left untreated, BPH causes obstruction of the urethra which usually results in increased urinary frequency, urgency, incontinence, nocturia and slow or interrupted urinary stream. BPH may also result in more severe complications, such as urinary tract infection, acute urinary retention, hydronephrosis and uraemia.
- A fairly recent treatment method for BPH involves microwave thermal therapy, in which microwave energy is employed to elevate the temperature of tissue surrounding the prostatic urethra above about 45° C., thereby thermally damaging the tumorous BPH tissue. Delivery of microwave energy to tumorous prostatic tissue is generally accomplished by a microwave antenna-containing applicator, which is positioned within a body cavity adjacent the prostate gland. The microwave antenna, when energized, heats adjacent tissue due to molecular excitation and generates a radiation pattern which encompasses and necroses the tumorous prostatic tissue. The necrosed intraprostatic tissue is subsequently reabsorbed by the body, thereby relieving an individual from the symptoms of BPH.
- One type of thermal therapy treatment of BPH is transurethral microwave thermotherapy. This method of treatment positions a Foley-type catheter containing a microwave antenna within the urethra adjacent to the prostate gland. The microwave antenna is energized to heat a selected volume of tumorous prostatic tissue surrounding the urethra to about 45° C. for a time sufficient to necrose the selected volume of tissue.
- Due to the relatively close proximity of the rectum to the urethra, it is critically important in the course of transurethral microwave thermotherapy that the temperature of the rectum is maintained below a threshold temperature. Rectal temperatures greater than the threshold may cause damage to the rectum.
- Typically, the temperature of rectal tissue adjacent the prostate is measured and monitored with a rectal temperature sensing probe. The probe supports one or more temperature sensing elements against a wall of the rectum adjacent to the prostate to provide the physician with essential information for controlling the location and degree of heat induced in the prostate. In providing a rectal probe to measure the temperature of rectal tissue adjacent the prostate, it is desirable to maintain the position of a temperature sensing device supported by the probe directly adjacent to the rectal wall to provide optimally accurate temperature readings. There is a continuing need for an improved rectal temperature sensing probe.
- The present invention is a temperature sensing probe assembly comprising a reusable temperature sensor/handle assembly and a balloon/sleeve assembly. The temperature sensor/handle assembly is comprised of a handle having a length, a width, a first end and a second end, and a temperature sensor strip carried by the handle and extending from the first end of the handle. The temperature sensor strip comprises a temperature sensor spaced from the first end. The temperature sensor is configured for connection to a thermometry device. The balloon/sleeve assembly comprises opposing first and second polymeric layers configured to define a balloon portion and a sleeve portion. The balloon portion further comprising a first interior space in communication with an interior space of the sleeve portion, and a second interior space isolated from the first interior space and the interior space of the sleeve portion. A first tube portion of an inflation tube is sealingly connected within the second interior space of the balloon portion and is configured with an inflation port. A second tube portion of the inflation tube extends through the sleeve portion and is configured for connection to a fluid source. The handle is reversibly positionable within the sleeve portion and the temperature sensor strip is reversibly positionable within the first interior space of the balloon portion.
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FIG. 1 is a top view of the rectal temperature sensing probe of the present invention. -
FIG. 2 is a bottom view of the rectal temperature sensing probe ofFIG. 1 . -
FIG. 3 is a bottom exploded view of the rectal temperature sensing probe ofFIG. 1 . -
FIG. 4 is an enlarged perspective view of the reusable probe handle and temperature sensor array of the rectal temperature sensing probe of the present invention. -
FIG. 5 is an exploded perspective view of the single use balloon/sleeve assembly of the rectal temperature sensing probe of the present invention. -
FIG. 6 is a cross-sectional view of the balloon/sleeve assembly of the present invention taken along line 6-6 ofFIG. 1 . -
FIG. 7 is a top view of the rectal temperature sensing probe of the present invention with the temperature sensing array partially inserted in a guide tube of the balloon/sleeve assembly. - While the above-identified drawing figures set forth preferred embodiments of the invention, other embodiments are also contemplated, as noted in the discussion. In all cases, this disclosure presents the present invention by way of representation and not limitation. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of this invention. It should be specifically noted that the figures have not been drawn to scale, as it has been necessary to enlarge certain portions for clarity.
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FIG. 1 is a top view of the rectaltemperature sensing probe 10 of the present invention. As shown inFIG. 1 ,probe 10 is generally comprised of aprobe handle 12 and a balloon/sleeve assembly 14. Theprobe handle 12 includes ahandle body 16 and atemperature sensor array 18 which carries a plurality of longitudinally spacedtemperature sensors 20. In one embodiment,handle 16 is preferably formed of silicone in a molding process that captures asensor cable 22, which is electrically connected tosensor array 18.Handle body 16 has a length of about 6.0 inches to about 6.5 inches and a nominal diameter of about 0.5 inches. -
Temperature sensor array 18 is comprised of the plurality oftemperature sensors 20 bonded to a flexible circuit which is housed within a protective strip. A suitable temperature sensor array is fully described in U.S. Pat. No. 5,792,070, which is incorporated herein by reference. In one embodiment,temperature sensor array 18 extends from aproximal end 24 ofhandle body 16, withtemperature sensor 20A positioned approximately 1.75 inches to about 2.15 inches fromproximal end 24.Temperature sensor array 18 has a length extending fromproximal end 24 ofhandle body 16 of about 4.4 inches to about 4.6 inches.Temperature sensors 20 are oriented and spaced to sense a temperature of a wall of the rectum facing the prostate whenprobe 10 is properly positioned within the rectum of a patient undergoing a heat treatment of the prostate.Sensor cable 22 is configured for connection to a rectal thermometry unit to transmit a signal representative of the sensed wall temperature, as is fully described in the aforementioned U.S. Pat. No. 5,792,070. - The balloon/
sleeve assembly 14 includes aballoon portion 26, which holds and carriestemperature sensor array 18, and asleeve portion 28, which enshrouds a portion of thehandle body 16. The balloon/sleeve assembly 14 is designed to be a disposable unit that can be separated from theprobe handle 12 after use ofprobe 10. Theballoon portion 26 andsleeve portion 28 are formed from layers of a flexible, biocompatible polymer, such as polyurethane, in a manner to be more fully described. As shown inFIG. 1 , theballoon portion 26 andsleeve portion 28 may be transparent to enable verification of a proper positioning of thetemperature sensor array 18 within theballoon portion 26. Theballoon portion 26 is formed with acentral channel 30, which positionstemperature sensor array 18 in a proper orientation relative to anouter surface 32 of theballoon portion 26. Withtemperature sensor array 18 properly positioned withinchannel 30,proximal end 24 of the probe handle 12 lies generally adjacent to awaist 34 of theballoon portion 26, which is a point of transition from theballoon portion 26 to thesleeve portion 28.Balloon portion 26 is dimensioned to fit within the rectum of a patient and engage the rectal wall when theballoon portion 26 is inflated, with theproximal end 24 of the probe handle 12 remaining external to the rectum. Aninflation tube 36, which is in communication with a fluid source, extends along the probe handle 12 and into theballoon portion 26 to inflate theballoon portion 26. Thesleeve portion 28 is sized to permit easy assembly and disassembly of the probe handle 12 from the balloon/sleeve assembly 14 and to cover thehandle body 16 whenprobe 10 is in use. -
FIG. 2 is a bottom view of theprobe 10 ofFIG. 1 . As shown inFIG. 2 ,inflation tube 36 extends along theprobe handle body 16 within achannel 38 formed relative to abottom surface 40 ofhandle body 16.Inflation tube 36 extends to atip 42 ofballoon portion 26 and is configured with abulbous end 44 in contact with thetip 42. Thebulbous end 44 is fixed relative to theinflation tube 36 to provide a blunt surface in contact with an inner surface ofballoon portion 26 for the safety of the patient in theevent tip 42 contacts patient tissues. In one embodiment,inflation tube 36 is provided with a plurality ofopenings 46 withinballoon portion 26 for the introduction of an inflation medium. The plurality ofopenings 46 are oriented on opposite sides ofinflation tube 36 to provide flexibility in a preferred plane to allow for anterior rectal wall contact oftemperature sensors 20 while maintaining column strength/flexural rigidity ofinflation tube 36 sufficient for insertion ofballoon portion 26 into the rectum. For increased flexibility atwaist 36, the size ofopenings 46 at or near towaist 36 may increased or elongated. -
Channel 38 ofhandle body 16 is dimensioned to secureinflation tube 36 relative to handlebody 16 wheninflation tube 36 is positioned therein. Accordingly, theelongated opening 48 ofchannel 38 has a width that is less than an outer diameter ofinflation tube 36 whenhandle body 16 is unstressed. Owing to the flexible characteristics of the silicone material forminghandle body 16, theopening 48, however, can yield sufficiently to permit theinflation tube 36 to be press fit into and removed fromchannel 38 with an application of sufficient force. In the absence of such force, the edges of opening 48 slightly overlap opposite sides ofinflation tube 36 to retaininflation tube 36 withinchannel 38. - A longitudinal movement of
inflation tube 36 relative to handlebody 16 is prevented by means of a lock assembly formed between a key 50 secured toinflation tube 36 and a corresponding key slot formed inhandle body 16 transverse tochannel 38. The key slot inhandle body 16 is positioned to align with the key 50 whentemperature sensing array 18 is fully inserted intocentral channel 30. The lock assembly further ensures that a precise location of thetemperature sensor array 18 within channel 30 (shown inFIG. 1 ) is maintained whenprobe 10 is in use. -
FIG. 3 is an exploded bottom view ofprobe 10 with the probe handle 12 separated from the balloon/sleeve assembly 14. As shown inFIG. 3 , probe handle 12 is removable and separable from the balloon/sleeve assembly 14 to permit probe handle 12, i.e., and thetemperature sensing array 18, to be reused with a new sterile balloon/sleeve assembly. The balloon/sleeve assembly 14 includes theinflation tube 36, which is connected between layers of the polymer material forming a balloon at thewaist 34 of theballoon portion 26, as will be described in greater detail. As shown inFIG. 3A , the key 50 consists of a polymeric member having aflat edge portion 52, acurved edge portion 54 and ahole 56 passing through the member to permit key 50 to be slid into a position oninflation tube 36 corresponding tokey slot 58 inhandle body 16. Oncekey 50 is properly positioned, it is secured toinflation tube 36 by a suitable adhesive. -
FIG. 4 is an enlarged perspective view of the probe handle 12, which shows that thehandle body 16 is configured with a curvedupper surface 60 and a flatlower surface 62. This configuration ofhandle body 16 facilitates a proper orientation of theprobe 10 relative to a patient and monitoring of the proper orientation during use. In a proper orientation, the flatlower surface 62 ofhandle body 16 contacts a treatment surface occupied by a patient in the supine position and is maintained in contact with the treatment surface by the weight of the patient on thehandle body 16. The configuration ofhandle body 16 thus inhibits any twisting ofprobe 10 by minor changes of position of the patient on the treatment surface. - As shown in
FIG. 4 ,temperature sensor array 18 extends from theproximal end 24 ofhandle body 16 at an upper extent ofhandle body 16, andsensor cable 22 extends rearward ofhandle body 16 at a comparable upper extent.Temperature sensor array 18 is oriented in a plane that is generally parallel with the flatlower surface 62 ofhandle body 16, withsensors 20 oriented on the upper surface of the flexible circuit. -
Channel 38 is generally centrally located relative to the flatlower surface 62.Channel 38 is defined by a curvedinner wall 64 which has an inner diameter that approximates the outer diameter of theinflation tube 36 for retaining theinflation tube 36 inchannel 38. The width of opening 48 ofchannel 38 is smaller than the inner diameter ofinner wall 64, which aids in the retention ofinflation tube 36 withinchannel 38. As shown in phantom, thekey slot 54 is dimensioned and configured complimentary to key 50 to form a friction fit with key 50 when it is position withinkey slot 54. -
FIG. 5 is an exploded view of the balloon/sleeve assembly 14. As shown inFIG. 5 , in one embodiment, the balloon/sleeve assembly 14 is comprised of a plurality of overlying andinterconnected layers Layers balloon portion 26 and thesleeve portion 28 of the balloon/sleeve assembly 14.Edge portion 77 oflayers sleeve assembly 14.Layers balloon portion 26, extending from afirst end 42A to anopposite end 78 corresponding towaist 34 of balloon/sleeve assembly 14. - Positioned between
layers layer 72 is aguide tube 80, which facilitates insertion of thetemperature sensor array 18 into theballoon portion 26.Guide tube 80 is formed of a flexible polymer, such a Fluorinated Ethylene Plastic or Fluorinated Ethylene Propylene and is skived along a portion of the tubewall facing layer 70 to minimize the amount of material ofballoon portion 26 that gets positioned within a patient, i.e., for patient comfort. Opposingedge portions 82 ofguide tube 80 are secured to the peripheral edge regions oflayers guide tube 80 in place.End 78 oflayer 72 is left unconnected relative to layer 70, such thatguide tube 80 separates layers 70 and 72 slightly for easy insertion of thetemperature sensor array 18.Layers seal lines 84 which definechannel 30 for thetemperature sensor array 18. - Positioned between
layers inflation tube 36.Inflation tube 36 is oriented with theflat edge portion 52 ofkey 50 facinglayer 76 and the axis ofopenings 46 perpendicular to theflat edge portion 52 ofkey 50.Inflation tube 36 is sealingly connected betweenlayers waist 34 and alongend 78.Layers layer 74 bearing directly againstlayer 72 and indirectly againstlayer 70 to urge thetemperature sensor array 18 in close proximity to the wall of the rectum to be monitored.Layer 76 in turn bears against an opposite rectal wall portion to secure theballoon portion 26 in place in the rectum. In a preferred embodiment layers 70, 72, 74 and 76 have a wall thickness of about 0.2 mil (i.e., about 0.002 inches), which provides for good heat transfer acrosslayer 70 tosensors 20 of thetemperature sensor array 18. - In an alternate embodiment, balloon/
sleeve assembly 14 may comprise only three layers consisting oflayers tube 80 is secured therebetween as previously described.Layers seal lines 84 to formchannel 30. Thereafter, inflation tube is positioned betweenlayers layer 76 to layer 72 about the perimeter and by sealing the side oflayer 72 facinglayer 76 to layer 76 alongend 78. - In yet another alternate embodiment,
layer 72 may be sized and shaped to definechannel 30 and sealed about its perimeter to layer 70, withguide tube 80 positioned as previously described betweenlayers layers layer 70 to layer 76 about the perimeter and by sealing the side oflayer 70 facinglayer 76 to layer 76 alongend 78. -
FIG. 6 is a cross-sectional view of thewaist 34 ofballoon portion 26, which shows the peripheral heat welds 90 that interconnect peripheral edge portions oflayers FIG. 6 also showsadhesive layers 92, which secure the opposingedge portions 82 ofguide tube 80 tolayers adhesive layer 94 is shown interconnectingend 78 oflayer 74 to layer 76 andinflation tube 36 to create a fluid-tight seal atend 78 and thereby form a balloon betweenlayers inflation tube 36. -
FIG. 7 is a top view of probe handle 12 being introduced into balloon/sleeve assembly 14 for assembly of rectaltemperature sensing probe 10. As shown inFIG. 7 , probe handle 12 is inserted throughsleeve portion 28 andtemperature sensor array 18 is positioned withinguide tube 80.Sleeve portion 28 maybe folded back overballoon portion 26 to facilitate locatingguide tube 80. In one embodiment, guidetube 80 is formed from a distinct color that is readily detectable through the transparent material forming balloon/sleeve assembly 14, which makes the opening fortemperature sensor array 18 intochannel 30 easy to identify. Probehandle 12 is advanced untiltemperature sensor array 18 is completely withinchannel 30, which occurs when key 50 oninflation tube 36 is aligned with thekey slot 54 in thehandle body 16.Inflation tube 36 is then press fit throughopening 48 and intochannel 38 along the length ofhandle body 16 and key 50 is press fit intokey slot 54. Withsleeve 28 coveringhandle body 16,temperature sensing probe 10 is then ready for insertion and use in a patient. -
Inflation tube 36 is flexible but with sufficient longitudinal stiffness to enable advancement oftip 42 ofballoon portion 26 into the desired position within the rectum of a patient.Balloon portion 26 is sized to engage the rectal wall when an inflation medium is introduced via theinflation tube 36 betweenlayers balloon portion 26. With the inflation medium evacuated from the balloon formed bylayers balloon portion 26 reduces to a more compact dimension for easy removal of theballoon portion 26 from the patient. To remove the balloon/sleeve assembly 14 from the probe handle 12, thesleeve portion 28 is everted overballoon portion 26 to isolate the contaminated surface ofballoon portion 26.Inflation tube 36 and key 50 are then easily withdrawn from thechannel 38 andkey slot 58 in thehandle body 16. With theinflation tube 36 separated from thehandle body 16, probe handle 12 easily slides out of the balloon/sleeve assembly for subsequent re-use with a new balloon/sleeve assembly. - Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes maybe made in form and detail without departing from the spirit and scope of the invention.
Claims (18)
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US11/091,107 US8409109B2 (en) | 2004-04-01 | 2005-03-28 | Rectal probe with disposable balloon assembly |
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US55874604P | 2004-04-01 | 2004-04-01 | |
US11/091,107 US8409109B2 (en) | 2004-04-01 | 2005-03-28 | Rectal probe with disposable balloon assembly |
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US20050222517A1 true US20050222517A1 (en) | 2005-10-06 |
US8409109B2 US8409109B2 (en) | 2013-04-02 |
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